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A Safety and Efficacy Study of Oral Dimebon in Patients With Mild-To-Moderate Alzheimer's Disease (CONNECTION)

This study has been completed.
Information provided by (Responsible Party):
Medivation, Inc. Identifier:
First received: May 7, 2008
Last updated: September 24, 2016
Last verified: September 2016
The Connection Study is a six-month confirmatory Phase 3 study to determine the safety and efficacy of Dimebon in the treatment of mild-to-moderate Alzheimer's disease (AD).

Condition Intervention Phase
Alzheimer's Disease
Drug: Dimebon
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Global Phase 3, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Oral Dimebon in Patients With Mild-to-Moderate Alzheimer's Disease (CONNECTION)

Resource links provided by NLM:

Further study details as provided by Medivation, Inc.:

Primary Outcome Measures:
  • To determine the effect of Dimebon as compared to placebo on the primary measure of cognition and memory, the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog). [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
  • To determine the effect of Dimebon as compared to placebo on the primary measure of global function, the Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus). [ Time Frame: Week 26 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the effect of Dimebon as compared to placebo on a measure of self care and daily function, the Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL). [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
  • To determine the effect of Dimebon as compared to placebo on a measure of behavior, the Neuropsychiatric Inventory (NPI). [ Time Frame: Week 26 ] [ Designated as safety issue: No ]

Enrollment: 598
Study Start Date: May 2008
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Dimebon, 5 mg orally three times daily
Drug: Dimebon
Dimebon, 5 mg orally three times daily for six months
Experimental: B
Dimebon 20 mg orally three times daily
Drug: Dimebon
Dimebon 20 mg orally three times daily for six months
Placebo Comparator: C
Placebo orally three times daily for six months
Drug: Placebo
Placebo three times daily for six months

Detailed Description:

This study is a randomized, placebo-controlled 6-month study designed as an adequate and well-controlled trial to demonstrate the safety and efficacy of Dimebon in the treatment of patients with mild-to-moderate AD. Dimebon is an investigational drug for Alzheimer's disease. The target of Dimebon's mechanism of action are the mitochondria (a cell's primary source of energy).The Connection Study is the second of two pivotal studies evaluating the effect of Dimebon. It is a 6-month study enrolling 525 patients in the United States, Europe, and South America. All patients completing the 6-month study will be eligible to receive Dimebon in an open-label extension trial.

The patient population will be carefully selected to ensure inclusion of patients with AD, rather than other types of dementia. Mild-to-moderate disease will be defined by the screening Mini-Mental State Examination (MMSE). Patients will attend study visits with caregivers who will provide information about the patient's condition.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Mild-to-Moderate Alzheimer's disease
  • Probable AD (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) and Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV)
  • MMSE score 10-24 inclusive
  • Computerized tomography (CT) san or magnetic resonance imaging (MRI) consistent with AD
  • Caregiver who cares for the patient at least 5 days per week

Exclusion Criteria:

  • Anti-dementia drugs including cholinesterase-inhibitors or N-methyl-D-aspartate receptor (NMDA) receptor antagonists within 90 days
  • Other causes of dementia
  • Other primary psychiatric or neurological disorders
  • Unstable medical illnesses or significant hepatic or renal disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00675623

  Hide Study Locations
United States, Arizona
Phoenix, Arizona, United States, 85004
United States, California
Costa Mesa, California, United States
Fresno, California, United States, 93720
Rancho Mirage, California, United States
United States, Connecticut
Hamden,, Connecticut, United States
New Haven, Connecticut, United States
Norwalk, Connecticut, United States
United States, Florida
Hallandale Beach, Florida, United States, 33009
Hialeah, Florida, United States
Miami, Florida, United States, 33137
North Miami, Florida, United States, 33161
Sunrise, Florida, United States, 33351
West Palm Beach, Florida, United States, 33407
United States, Indiana
Indianapolis, Indiana, United States, 46260
United States, Kentucky
Paducah, Kentucky, United States, 42003
United States, Massachusetts
Newton, Massachusetts, United States, 02459
United States, Michigan
Ann Arbor, Michigan, United States
United States, Missouri
St. Louis, Missouri, United States, 63044
United States, New York
Brooklyn, New York, United States
Cedarhurst, New York, United States, 11516
New York City, New York, United States
Rochester, New York, United States, 14620
Staten Island, New York, United States
United States, North Carolina
Morganton, North Carolina, United States, 28655
United States, Ohio
Centerville, Ohio, United States
United States, Pennsylvania
Norristown, Pennsylvania, United States
United States, Texas
Austin, Texas, United States
United States, Wisconsin
Middleton, Wisconsin, United States, 53562
Sponsors and Collaborators
Medivation, Inc.
Study Director: Lynn Seely, MD Medivation, Inc.
  More Information

Responsible Party: Medivation, Inc. Identifier: NCT00675623     History of Changes
Other Study ID Numbers: CONNECTION  DIM14 
Study First Received: May 7, 2008
Last Updated: September 24, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Medivation, Inc.:
Alzheimer's disease, clinical trial, memory loss, mitochondria,
investigational drug, neurodegenerative disease, dementia

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders processed this record on October 21, 2016